Vitamin D Therapy in Patients With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00418587
Last Updated: 2018-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2006-12-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
800 IU oral daily dose level
Cholecalciferol
800 IU oral daily
2
2000 IU oral daily dose level
Cholecalciferol
2000 IU oral daily
3
4000 IU oral daily dose level
Cholecalciferol
4000 IU oral daily
Interventions
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Cholecalciferol
800 IU oral daily
Cholecalciferol
2000 IU oral daily
Cholecalciferol
4000 IU oral daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* African American, participating in the SLE in Gullah Health (SLEIGH) Study
* Outpatient
* Stable disease with no BILAG A or B in any system for the past 4 weeks
* Stable prednisone (or equivalent corticosteroid) dose ≤ 20 mg/day for ≥ 4 weeks prior to study entry
* Baseline 25(OH)D concentration of \< 30 ng/ml
* Willingness to discontinue other vitamin D supplements and/or multivitamins containing vitamin D while participating in the study
* Age 18 - 85 years
* Ability to complete questionnaires in English
* Ability to give informed consent
Exclusion Criteria
* Liver disease (serum ALT, AST \>2x normal) or total serum bilirubin \>1.5x normal
* History of renal stones
* Current treatment with any dose of cyclophosphamide
* Dialysis or creatinine \> 2.5 mg/dL
* Pregnancy
* Current drug or alcohol abuse
* Anticipated poor compliance
18 Years
85 Years
ALL
No
Sponsors
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American College of Rheumatology Research and Education Foundation
OTHER
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Principal Investigators
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Diane L Kamen, MD, MSCR
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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MUSC-GAC734-HR16356
Identifier Type: -
Identifier Source: org_study_id
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